Bone fracture repairs and spinal fusions often require a biologic boost to grow bone. Autograft is the most clinically desired treatment option due to its proven safety and efficacy profile. Autograft is osteogenic, osteoinductive and osteoconductive, and comes with zero risk of rejection. However, autograft treatment can present problems due to morbidity issues associated with harvesting the graft from, for example, the patient's iliac crest, and because the needed volume of autograft is not always available. Thus there is an existing clinical need for non-autograft based osteoinductive and osteogenic treatment options.
Osteoinduction is a complex pathway involving multiple layers of redundancy with growth factors, hormones, stem cells and a host of other factors contributing to the process. Current growth factor treatments, such as bone morphogenic proteins (BMPs), are sometimes subject to super-physiological dosing which can have undesired side-effects and may not be the best solution. Osteoinduction treatments have classically been defined by factors or matrices that can stimulate bone growth de novo, for example BMP-2 and BMP-7. Bone healing is a multi-faceted closely coordinated process that involves different cells and biological processes that are controlled and managed through a variety of cellular signaling pathways. Human growth factors, such as BMPs, often drive these pathways and administration of them therapeutically represents one way of impacting bone growth.
However, given the extensive pathways that intersect to trigger bone growth there are potential technologies with osteoinductive properties beyond BMPs.